BioMerieux mini APT User manual

Ref. 99709 Version C 11/2003

mini API

Instrument User's Manual

bioMérieux® SA 69280 Marcy l'Etoile / France

Tel. [phone] - Fax [phone] http://www.biomerieux.com

Printed in France / 673 620 399 RCS Lyon

V.AB 09.2003

Argentina

bioMérieux Argentina s.a.

Av. Congreso 1745 (C1428BUE) Capital Federal Buenos Aires

tel. [phone] fax [phone]

Australia

bioMérieux Australia Pty. P/L

Unit 25, Parkview Business Center 1 Maitland Place

Baulkham Hills NSW 2153 tel. [phone]

fax [phone]

Austria

bioMérieux Austria GmbH

Eduard-Kittenberger-Gasse 97 Top 3

A-1230 Wien

tel. [phone] fax [phone]

Belgium

bioMérieux Benelux s.a./n.v.

Media Square

18-19 Place des Carabiniers Bruxelles 1030

tel. [phone] fax [phone]

Brazil

bioMérieux Brasil SA

Estrada Do Mapuá 491 Jacarepaguá

CEP 22710 261 Rio de Janeiro R.J tel. [phone]

fax [phone]

Canada

bioMérieux Canada, Inc.

4535, Dobrin

Saint Laurent (Québec) H4R 2L8 tel. [phone]

fax [phone]

Chile

bioMérieux Chile S.A.

Seminario 131 Providencia Santiago

tel. [phone] fax [phone]

China

bioMérieux China Limited

Unit 1701-2, 17/F, Nanyang Plaza No. 57 Hung To Road, Kwun Tong Kowloon - Hong Kong

tel. [phone] fax [phone]

Colombia

bioMérieux Colombia Ltda

Diagonal 109 # 20A - 33 Bogotá

tel. [phone] fax [phone]

Denmark

bioMérieux Danmark Aps

Smedeholm 13C, 2730 Herlev

tel. [phone] fax [phone]

Finland

bioMérieux Suomi Oy

Rajatorpantie 41 C 01640 Vantaa

tel. [phone] fax [phone]

France

bioMérieux SA

69280 Marcy l’Etoile tel. [phone] fax [phone]

http://www.biomerieux.com

Germany

bioMérieux Deutschland GmbH

Weberstrasse 8

D 72622 Nürtingen tel. [phone] fax [phone]

Greece

bioMérieux Hellas S.A.

Papanikoli 70

15232 Halandri Athens

tel. [phone] fax [phone]

India

bioMérieux India Pvt. Ltd

D-45, Defense Colony New Delhi 110 024 tel. [phone] fax [phone]

Indonesia

bioMérieux Asean

Enseval Building

Kawasan Industri Pulo Gadung - JI. Pulo Lentut No. 10

Djakarta Timur 13920 tel. [phone] fax [phone]

Italy

bioMérieux Italia S.p.A.

Via Fiume Bianco, 56 00144 Roma

tel. [phone] fax [phone]

Ivory Coast

bioMérieux Afrique Occidentale

08 BP 2634

Rue Joseph Blohorn - Cocody Abidjan 08

tel. [phone] fax [phone]

Japan

bioMérieux Japon, Ltd.

Seizan Bldg.,

12-28 Kita-Ayoama 2-chome

Minato-ku, Tokyo 107-0061 tel. [phone]

fax [phone]

Korea

bioMérieux Korea Co., Ltd.

7th floor Yoosung Building

# 830-67, Yoksam-dong, Kangnam ku Séoul

tel. [phone] fax [phone]

Mexico

bioMérieux México SA de CV

Chihuahua 88, col. Progreso México 01080, D.F.

tel. [phone] fax [phone]

Netherlands (The)

bioMérieux Benelux BV

Boseind 15

P.O. Box 23 5280 AA Boxtel

tel. [phone] fax [phone]

New Zealand

bioMérieux New Zealand Ltd.

22/10 Airbourne Road North Harbour Auckland

tel. [phone] fax [phone]

Norway

bioMérieux Norge AS

kernveien 145 N - 0513 Oslo

tel. [phone] fax [phone]

Philippines (The)

Representation office bioMérieux Philippines

11th Floor, Pearlbank Centre

146 Valero Street, Salcedo Village

1227 Makati City tel. [phone] fax [phone]

Poland

bioMérieux Polska Sp. Z o.o. ul. Zeromskiego 17

01-882 Warszawa tel. [phone] fax [phone]

Portugal

bioMérieux Portugal, Lda.

Rua Alto do Montijo, Lotes 1 e 2 Portela de Carnaxide

2794-070 Carnaxide tel. [phone] fax [phone]

Russia

o.o.o. bioMérieux

Petrovsko-Razoumovskii proyezd, 29 127287 Moscow

tel. [phone]

(7) 095 424 79 38 fax [phone]

Spain

bioMérieux España s.a.

Manual Tovar, 36 28034 Madrid

tel. [phone] fax [phone]

Sweden

bioMérieux Sverige AB

Hantverksvägen 15 436 33 Askim

tel. [phone] fax [phone]

Switzerland

bioMérieux Suisse s.a.

51, avenue Blanc Case postale 2150 1211 Genève 2

tel. [phone] fax [phone]

Taiwan

Representation office

bioMérieux China Limited - Taiwan Branch

RM 608, No. 6-3 Ching Cheng Street Taipei 105

tel. [phone] fax [phone]

Thaïland

bioMérieux Thaïland Ltd

Regent House Bldg, 16 th Floor

183 Rajdamri Road, Lumpini, Pathumwan Bangkok 10330

tel. [phone] fax [phone]

Distribution in over 130 countries

Turkey

bioMérieux Diagnostik A.S.

Yenisahra Mah. Caliskan Sok. No. 4 34746 Kadiköy / Istanbul tel. [phone] fax [phone]

United Kingdom

bioMérieux UK Ltd

Grafton way, Basingstoke Hampshire RG22 6HY tel. [phone] fax [phone]

USA

bioMérieux, Inc.

100 Rodolphe Street

Durham NC 27712 tel. [phone] fax [phone]

Vietnam

Representation office bioMérieux Vietnam Rep. Office

Sai Gon Center Bldg. 11th Fl. 65 Le Loi District 1

Ho Chi Minh City tel. [phone] fax [phone]

V.A 09/2003

This document will be updated for each software modification or any other change.

Information supplied in this document is subject to modification before the products described become available.

This document may contain information or references concerning certain bioMérieux® SA products, programs and services not available in such country; this, however, shall not mean that bioMérieux® SA intends to commercialize such products, programs or services in such country.

To request copies of publications or for any technical request, contact bioMérieux® SA or your local distributor.

L i a b i l i t y d i s c l a i m e r

bioMérieux® SA disclaims all warranties, guarantees or liabilities, express or implied arising by law or otherwise with respect to this manual, its quality, accuracy or performance, including without limitation, any obligation of bioMérieux® SA with respect to MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE, noninfringement and consequential or incidental damages. IN NO EVENT SHALL bioMérieux® SA’ s LIABILITY TO CUSTOMER UNDER ANY CLAIM EXCEED A REFUND OF THE AMOUNT PAID TO bioMérieux® SA FOR THE PRODUCT OR SERVICE WHICH IS THE SUBJECT OF THE CLAIM.

In no event shall bioMérieux® SA be bound by the manual. bioMérieux® SA shall have the right to modify the manual without notice.

b i o M é r i e u x ® S A C o p y r i g h t

This manual, its content and graphics are copyrighted by bioMérieux® SA.

In no event does bioMérieux® SA concede to the manual's user any right for reproduction, adaptation or translation, by any process and in any country whatsoever.

All editorial content and graphics (including without limitations, all articles, text , images, logos, compilations, designs) are protected by French Copyright Law and international treaties and may not be copied without the express permission of bioMérieux® SA.

Any representation or reproduction whether partial or integral, by any process whatsoever, would therefore be considered fraudulent and sentenced by the applicable law.

The logo is a registered and protected trademark of bioMérieux® SA or one of its subsidiaries.

General w arnings

DANGER ! All biological fluids should be considered as potentially infectious.

Protective gloves must be worn when manipulating blood, products derived from blood or objects contaminated with blood.

Qualified laboratory personnel should use acceptable procedures for biohazardous material.

IMPORTANT!	The user is advised to read and understand all instructions in this manual
	to	be able to	derive the best performance from the	mini API®.
	The accuracy of results obtained with this instrument depends, in
	particular, on the maintenance operations described in this manual.
	The user should be aware that if the maintenance operations are not
	performed, are only partially performed, or are not performed as described
	in this manual, bioMérieux® SA is in no case liable for any false test
	results obtained.
	The configuration that you have purchased is adapted to the legislation
	and	standards	of the different countries it will be	sent to.
	For this reason, it may differ from the one presented in this document.
	However it will not prevent mini API® from operating correctly.
WARNING!	This product is an in vitro diagnostic medical device. It complies with the
	directives and standards mentioned in the certificate supplied with it.

However, this instrument may cause harmful interference if not installed in accordance with the instruction manual.

bioMérieux® SA recommends that you observe the different warnings inscribed on the instrument itself and indicated in the documentation supplied.

WARNING! Changes to the equipment not expressly approved by bioMérieux® SA could void conformity and thus the user’s authority to operate the equipment. The user will be required to repair damage at his own expense.

bioMérieux SA is in no case liable for any damage that may arise from failure to comply with technical specifications in this manual, from the handling of biological fluids or any operation conducted on the equipment not in compliance with these mandatory standards.

R e visions

The list of revision below summarizes replacements or additional pages in your mini API® Instrument User's Manual.

Manual	Reason	Page(s)
V.B 04/2001	New format (7x9)	All
V.C 10/2003	CE marking	Cover page
		Chapter 1
		Chapter 6

mini API® Instrument User's Manual

Revisions-1

Table of contents

List of figures	VI-1
1 How to use this manual	1-1
Introduction ...............................................................................................................................................	1-1
Finding topics and procedures..................................................................................................................	1-2
Typographic conventions ..........................................................................................................................	1-3
Graphic symbols .......................................................................................................................................	1-4
2 Functional description of mini API®	2-1
Introduction ...............................................................................................................................................	2-1
Description / aim .......................................................................................................................................	2-1
Configuration components ........................................................................................................................	2-2
Hardware ...........................................................................................................................................	2-2
Software.............................................................................................................................................	2-2
Consumables.....................................................................................................................................	2-2
General features and technical specifications of the analyzer ..................................................................	2-4
Environmental conditions ......................................................................................................................	2-4
Physical features ...................................................................................................................................	2-4
Electrical characteristics ........................................................................................................................	2-5
Characteristics of optical components...................................................................................................	2-5
Principle of operation ................................................................................................................................	2-7
Turbinephelometric reading...................................................................................................................	2-7
Colorimetric reading ..............................................................................................................................	2-8
3 Preliminary instructions	3-1
Introduction ...............................................................................................................................................	3-1
Recommendations for installation and use ...............................................................................................	3-1
Unpacking mini API® ................................................................................................................................	3-2
Assembly and installation..........................................................................................................................	3-3
Choosing a location...............................................................................................................................	3-4
Setting up the strip carriage...................................................................................................................	3-5
Connections ..........................................................................................................................................	3-6
Preparing for operation..........................................................................................................................	3-6

mini API® Instrument User's Manual

V-1

Table of contents

4	Set-Up	4-1
Starting mini API®.....................................................................................................................................		4-1
Adjusting the contrast and brightness of the screen..................................................................................		4-2
Printer operation........................................................................................................................................		4-3
	Functions...............................................................................................................................................	4-4
Checking the operation of the printer (self-test) ........................................................................................		4-5
Stopping mini API®...................................................................................................................................		4-6
5	Using mini API®	5-1
Procedure for use......................................................................................................................................		5-1
6	Maintenance	6-1
Testing mini API® .....................................................................................................................................		6-2
Maintenance..............................................................................................................................................		6-3
	Cleaning mini API® ...............................................................................................................................	6-3
Changing the ribbon..................................................................................................................................		6-9
Changing the roll of paper.......................................................................................................................		6-11
Changing the fuse...................................................................................................................................		6-13
7	Troubleshooting	7-1
8	DENSIMAT densitometer	8-1
9	Electronic pipette	9-1
10	Appendices	10-1
Appendix A: Installing MS DOS 6.22 or later versions ............................................................................		10-1
Appendix B: Installing the mini API® CONFIGURATION floppy disk......................................................		10-2
Appendix C: Protecting data on floppy disks through write inhibit...........................................................		10-3
11	Glossary	11-1
12	Index	12-1
Notes		Notes-1

V-2	mini API® Instrument User's Manual

List of figures

2 Functional description of mini API
	Fig. 2-1: Configuration components ........................................................................................................	2-1
	Fig. 2-1 : Using mini API®.......................................................................................................................	2-3
	Fig. 2-2: Description of the spectral zone................................................................................................	2-6
	Fig. 2-3: Reading principle of the test strip reader ..................................................................................	2-6
3.	Preliminary instructions
	Fig. 3-1: Setting up the strip carriage ......................................................................................................	3-5
	Fig. 3-2: Connections..............................................................................................................................	3-6
4.	Set-Up
	Fig. 4-1: Back panel of mini API® ...........................................................................................................	4-1
	Fig. 4-2: Adjusting the contrast and brightness of the screen .................................................................	4-2
	Fig. 4-3: Printer control panel..................................................................................................................	4-3
	Fig. 4-4: Print-out during the self-test......................................................................................................	4-5
5. Using mini API®
	Fig. 5-1: Position of the strip carriage and the protection rail ..................................................................	5-3
6.	Maintenance
	Fig. 6-1: Strip carriage assembly. ...........................................................................................................	6-4
	Fig. 6-2: Strip carriage ............................................................................................................................	6-4
	Fig. 6-3: Preparing the photodiode cleaning tool.....................................................................................	6-7
	Fig. 6-4: Cleaning the photodiodes .........................................................................................................	6-7
	Fig. 6-5: Printer cover .............................................................................................................................	6-9
	Fig. 6-6: Paper cutter ..............................................................................................................................	6-9
	Fig. 6-7: Changing the ribbon ...............................................................................................................	6-10
	Fig. 6-8: Loading paper.........................................................................................................................	6-12
	Fig. 6-9: Back panel of mini API® .........................................................................................................	6-13

mini API® Instrument User's Manual

VI-1

1 How to use this manual

I n t r o d u c t i o n

The mini API® Instrument Manual deals solely with the instrument and consumables. It includes the information you need for the installation, set-up and maintenance of mini API®.

The software and the procedures for use are described in the mini API® Procedures Manual.

CAUTION!	The user is advised to read and understand all instructions in this manual
	to be able to derive the best performance from mini API®.

mini API® Instrument User's Manual

1-1

How to use this manual

Finding topics and procedures

F i n d i n g t o p i c s a n d p r o c e d u r e s

	The information in the manual is organized in 12 chapters. The first 7 contain
	the topics and procedures.
	Chapter 8 describes the DENSIMAT densitometer.
	Chapter 9 describes the electronic Pipette.
	Chapter 10 includes the Appendices.
	Chapter 11 is the glossary.
	Chapter 12 is the Index.
Table of contents	The main table of contents of the manual is located on pages V-1 to V-2.
	It lists each chapter and the procedures and/or topics contained in the manual.
List of figures	Page VI-1 contains the list of figures found in this manual.
Graphic symbols	The standard symbols used for our instruments and their meanings can be
	found in this list (Page 1-4 to 1-6).
Page headers and	Apart from the first page of every chapter, each page of the manual includes a
page footers	page header and a footer.
	Each page header includes the chapter title and the title of a procedure or its
	corresponding description.
	These titles are located on the outside of the page so that you can thumb
	through the pages to quickly locate a chapter or a procedure.
	The footers contain the title of the manual, the name of the product and the
	page number.
Glossary	The glossary is located in chapter 11 at the back of the manual. It gives the
	definition of the main technical terms used in the manual.
Index	The index is located in chapter 12 at the back of the manual. It is used to locate
	a particular description or procedure.

1-2	mini API® Instrument User's Manual

How to use this manual

Typographic conventions

T y p o g r a p h i c c o n v e n t i o n s

<Return>

<Ctrl>

Following are the terms and visual cues used in this manual to aid in your

understanding of the procedures.

1

	The bullet point is used to denote an action to be performed.
	Can also be < > or <Enter> depending on the type of keyboard.
	This key is always associated with another key.
	Both keys should be pressed simultaneously.
E.g.:	Press <Ctrl> U.

<Esc>

<NumLock>

< >, < >, < > and < >

A B C 1 2 3

E.g.:

A B C 1 2 3

E.g.:

This key is sometimes used to quit the menu.

This key must be activated (light on) before you can use the numeric keyboard.

These keys enable you to move the cursor in different directions on the screen.

The < > key is also called <Cursor up> in the software.

This typography is used for messages that appear on the screen. C : \ >

This typography is used to represent a text to be typed through the computer keyboard.

Type: A P I C O N F

mini API® Instrument User's Manual

1-3

How to use this manual

Graphic symbols

G r a p h i c s y m b o l s

V.A 09/2003

The standard symbols used for our systems and their meanings can be found below:

Direct current

Alternating current

Both direct and alternating current

Three-phase alternating current

Earth (ground) TERMINAL

PROTECTIVE CONDUCTOR TERMINAL

Frame or chassis TERMINAL

Equipotentiality

ON (power supply)

OFF (power supply)

1-4	mini API® Instrument User's Manual

How to use this manual

Graphic symbols

ON" (only for a component of the system equipment)

"OFF" (only for a component of the system equipment)

1

Equipment protected throughout by DOUBLE INSULATION or

REINFORCED INSULATION (equivalent to Class II of IEC 536)

Caution !: risk of electric shock

(background color: yellow, symbol and outline: black)

Caution !: see accompanying documents (background color: yellow, symbol and outline: black)

Caution !: high temperature

Caution !: potential pinch point

Caution !: potential biohazard

i

Consult instructions for use

LOT	Batch code

REF

Catalogue number

	Temperature limitation
EC REP	Authorised representative
mini API® Instrument User's Manual		1-5

How to use this manual

Graphic symbols

	Keep dry
	Manufactured by
	Date of manufacture
IVD	In vitro diagnostic medical device

SN

Serial number

Keep away from magnetic field

1-6	mini API® Instrument User's Manual

2 Functional description of mini API ®

I n t r o d u c t i o n

This manual deals with the mini API® instruments and consumables.

The software is described in the mini API® Procedures Manual.

D e s c r i p t i o n / a i m

mini API® is designed for the automatic identification and susceptibility testing of

ID 32, rapid ID 32, ATB® and rapid ATB® strips.

It also enables computer assisted interpretation of API® strips read visually.

-mini API®

-Keyboard

-Electronic pipette

-DENSIMAT densitometer

Fig. 2-1 : Configuration components

mini API® Instrument User's Manual

2-1

Functional description of mini API®

Configuration components

C o n f i g u r a t i o n c o m p o n e n t s

mini API® is an automated instrument for identification and susceptibility testing. It consists of:

		the hardware,
		the software,
		the consumables.
Hardware	The package includes:
	mini API®, a self-contained analytical module enabling:
		reading of test strips,
		management of results and data,
		printing of results obtained,
	a DENSIMAT densitometer to standardize the turbidimetry of the bacterial
		suspension (please refer to the manual supplied with the densitomer).
	an electronic Pipette to dispense the required amount of bacterial
		suspension into each cupule of the identification and susceptibility test strips
		(55 µl or 135 µl) (please refer to the manual supplied with the pipette).
Software	The mini API software enables:
		interpretation of data,
	interpretation of strip results (identification or susceptibility tests),
	expert analysis of susceptibility tests,
	storage of results on the hard disk,
		printing of results,
		extraction of data,
	connection with a central computer.
Consumables	The mini API® consumables include:
	strips with associated media and reagents (see package inserts),
	ribbons and paper for the printer,
		pipette tips.

2-2	mini API® Instrument User's Manual

Functional description of mini API®

Configuration components

Isolation

Isolation medium.

Standardization of the

Orientation tests

Choice of

inoculum using the

DENSIMAT

strips

Automated

technique

Manual technique

Standardized

inoculation using the

2

electronic pipette

Visual reading.

Entry of biochemical profiles via keyboard.

Automatic interpretation.

ATB or rapid	ATB strips		ID 32 or rapid ID 32strips

Automatic reading and interpretation.

Fig. 2-2 : Using mini API®

mini API® Instrument User's Manual

2-3